# FDA recall Z-0004-2019

> **Varian Medical Systems** · Class II · device recall initiated 2018-08-20.

## Product

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5  EDGE Radiotherapy Delivery System version 2.0 and 2.5    Product Usage:  The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

## Reason for recall

Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.

## Distribution

Worldwide Distribution - US nationwide in the states of AL, AR, AZ, CA, CO, FL, Guan, IL IN, KS, KY, LA, MA, MD, MI, MO, NH, NJ, NY, OH, OK, PA, Puerto Rico, TN, TX, VA, WI and the countries of :  Algeria, Australia, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, India, Ireland, Israel, Italy, Japan, Kazakhstan, Lebanon, Morocco, Nepal, The Netherlands, New Zealand, Norway, Panama, Poland, Reunion Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and United Kingdom

## Key facts

- **Recall number:** Z-0004-2019
- **Recalling firm:** Varian Medical Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-20
- **Report date:** 2018-10-10
- **Termination date:** 2020-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Palo Alto, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0004-2019

## Citation

> AI Analytics. FDA recall Z-0004-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0004-2019. Source: US FDA. Licensed CC0.

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